MAUDE Adverse Event Report: BIOMET UK LTD OXF ANAT BRG LT SM SIZE 3 PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Cyst(s) (1800); Pain (1994)

Event Type  Injury  

Event Description

It was reported that a patient enrolled in a clinical study underwent left partial knee arthroplasty on (b)(6) 2008.Subsequently, patient reported pain on (b)(6) 2008 that was resolved with an injection.Additionally, a bakers cyst was found on the left knee during a follow-up visit on (b)(6) 2009.Finally, the patient's relative reported in the seven year survey on (b)(6) 2015 that patients knee goes out frequently, but she is in poor health and could not withstand surgery to revise.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.

• Brand Name: OXF ANAT BRG LT SM SIZE 3 PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD; waterlon industrial estate; bridgend, south wales CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4821997
• MDR Text Key: 15968481
• Report Number: 0001825034-2015-02448
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/31/2011
• Device Model Number: N/A
• Device Catalogue Number: 159540
• Device Lot Number: 1202559
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2015
• Initial Date FDA Received: 06/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Weight: 52